Indikation (Clinical Trials):
Ovarian Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Technical University of Munich
Collaborator:
University of Hohenheim, University Hospital Schleswig-Holstein, University of Leipzig, University of Cologne,
Studienleiter
Marion Kiechle, Prof. Dr. Study Director Technical University of Munich Martin Halle, Prof. Dr. Study Director Technical University of Munich Stephan C Bischoff, Prof. Dr. Study Director Universitaet Hohenheim, Stuttgart Michael Siniatchkin, Prof. Dr. Study Director Universitätsklinikum Schleswig-Holstein, Campus Kiel Markus Loeffler, Prof. Dr. Study Director University of Leipzig Christoph Engel, PD Dr. Study Director University of Leipzig Rita K Schmutzler, Prof. Dr. Study Director University of Cologne Alfons Meindl, Prof. Dr. Study Director Technical University of Munich Anne S Quante, Dr. Principal Investigator Technical University of Munich
Kontakt
Marion Kiechle, Prof. Dr. Kontakt: Phone: +49 89 4140 2420 E-Mail: marion.kiechle@tum.de» Kontaktdaten anzeigen Daniela Schemmer Kontakt: Phone: +49 89 4140 2433 E-Mail: Daniela.Schemmer@mri.tum.de» Kontaktdaten anzeigen
Studienlocations (3 von 19)
Humboldt Universität zu Berlin Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden (Sachsen) GermanyRekrutierend» Google-MapsDarmkrebszentrum Universitätsklinikum Düsseldorf Moorenstraße 5 40225 Düsseldorf DeutschlandRekrutierend» Google-Maps
Interdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte Henricistraße 92 45136 Essen (Nordrhein-Westfalen) DeutschlandRekrutierend» Google-MapsKinderonkologisches Zentrum Universitätsklinikum Essen Hufelandstraße 55 45147 Essen DeutschlandRekrutierend» Google-MapsUniversitätsklinikum Freiburg Freiburg (Baden-Württemberg) GermanyRekrutierend» Google-MapsBrustzentrum der Universitätsmedizin Göttingen Robert-Koch-Straße 40 37075 Göttingen DeutschlandRekrutierend» Google-MapsBrustzentrum am Universitätsklinikum Hamburg-Eppendorf Martinistraße 52 20251 Hamburg DeutschlandRekrutierend» Google-MapsLeberkrebszentrum Medizinische Hochschule Hannover Carl-Neuberg-Straße 1 30625 Hannover DeutschlandRekrutierend» Google-MapsUniversitätsklinium Heidelberg Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitätsklinikum Schleswig-Holstein, Campus Kiel Kiel (Schleswig-Holstein) GermanyRekrutierend» Google-MapsUniklinikum Köln Köln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsGynäkologisches Tumorzentrum am Universitätsklinikum Leipzig 4103 Leipzig DeutschlandNoch nicht rekrutierend» Google-MapsTechnische Universität München München (Bayern) GermanyRekrutierend» Google-MapsGynäkologisches Krebszentrum Regensburg der Frauenklinik der Universität Regensburg Landshuter Straße 65 93053 Regensburg DeutschlandRekrutierend» Google-MapsInterdisziplinäres Brustzentrum am Diakonieklinikum Stuttgart (Baden-Württemberg) GermanyRekrutierend» Google-MapsViszeralonkologisches Zentrum Universitätsklinikum Tübingen Hoppe-Seyler-Straße 3 72076 Tübingen DeutschlandRekrutierend» Google-MapsUniversität Ulm Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsOnkologisches Zentrum Universitätsklinikum Würzburg Josef-Schneider-Straße 6 97080 Würzburg DeutschlandRekrutierend» Google-Maps
2. body mass index (BMI) (Time Frame - 12 months): Body weight (in kilograms) divided by body height (in meters) squared.
3. ventilatory threshold 1 (VT1) in spiroergometry (Time Frame - 12 months): ventilatory threshold VT1 in spiroergometry
Secondary outcome:
1. stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire (Time Frame - 3, 12, 24, 36 months): (TICS) questionnaire
2. grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire (Time Frame - 3, 12, 24, 36 months): Life Orientation Test (LOT)
3. attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire (Time Frame - 3, 12, 24, 36 months): (BKAE) questionnaire
4. quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (Time Frame - 3, 12, 24, 36 months): (EORTC QLQ-C30)
5. maximum oxygen consumption (VO2max), as measured by spiroergometry (Time Frame - 3, 12 months): spiroergometry
6. physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) (Time Frame - 3, 12, 24, 36 months): Physical Activity
7. incidence of breast cancer (Time Frame - 12, 24, 36 months): During study
9. body mass index (BMI) (Time Frame - 3, 12, 24, 36 months): (BMI)
10. change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry (Time Frame - 3, 12 months): spiroergometry
11. mortality rate (Time Frame - 12, 24, 36 months): During study
15. dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) (Time Frame - 3, 12, 24, 36 months): (EPIC-FFQ)
16. serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin (Time Frame - 3, 12, 24, 36 months): Blood Test
No Intervention: Control Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer
Experimental: Intervention Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.
